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HIV self-test kits may speed up diagnosis but they're not for 'the morning after'

There's a growing - almost silent - market for HIV self-testing kits. It's a young market, and communities clearly need guidance. But health professionals say self-testing may help us end the AIDS epidemic.

Targets and goals can be positive and negative. The United Nations has a fair few for HIV/AIDS.

One goal is to end the HIV epidemic by 2030. It's not that HIV will be eradicated but that the epidemic, such as it is in 2016, with 37 million people living with the virus, should be brought under control.

While most people would say this was a good idea - we should all aspire to such global health efforts - there's a concern such goals distract us from working towards a sustained response and understanding of what that requires from science, healthcare and in money.

"The price tag of all of that by 2030 is far beyond our current means," said Mitchell Warren of the AIDS Vaccine Advocacy Coalition (AVAC) in an interview with DW. "I worry that we've sold people on a concept that is not funded appropriately."

Tall order: 90-90-90

Then there's the UN's more immediate "90-90-90" targets. The first target is for "90 percent of all people with HIV to know their status by 2020." The second is to get 90 percent on treatment, and the third is that 90 percent of all people on antiretroviral therapy are to have "durable viral suppression."

It's a tall order - even just the first target. UNAIDS data from 2015 suggest only 54 percent of people currently living with HIV (PLHIV) know their status. That's 35 years into the epidemic. And in four year's time we want to diagnose a further 46 percent?

The problem so far

Until now, one of the main problems has been access to medical services. A growing range of HIV self-test kits, however, are bringing renewed hope of achieving the 90-90-90 targets.

The Imperial College/DNA Electronics device uses a drop of blood to detect HIV and sends results via signal to a computer

Self-test kits could enable testing in remote areas or "non-formal" settings. But it is a largely untested technology and, as a result, the World Health Organisation (WHO) has published new guidelines for its implementation.

"We've done well in antenatal clinics - lots of women are offered tests there - and in some countries up to 80 percent of women already know their HIV status," says Dr. Rachel Baggaley, who oversees HIV self-testing (HIVST) at the WHO. "But men and people from what we call 'key populations' - men who have sex with men, sex workers, transgender people, people who inject drugs, and people in prison - they have much lower rates of testing."

STAR project Africa

The WHO has joined with UNITAID and global health non-profit PSI to run an HIVST project in Africa called STAR. The first phase is in Malawi, Zambia and Zimbabwe, and phase two will see it expand to South Africa.

They are using a range of devices to test how they can be distributed and used in communities. Their aim is "to catalyze the market for companies to produce high-quality devices."

None of the devices are WHO prequalified, or by the Global Fund, in a process for testing diagnostics, medicines and vaccines for "high burden diseases." But they will have been tested by national bodies.

"We're seeing that people who are used to technology, maybe more urban, are more able to pick up a self-test kit and follow the instructions, but people in rural communities, or those doing this for the first time, may need a bit of support - community groups who can do a demonstration or support people if the test is positive," says Baggaley.

A range of tests

One of the kits the STAR project uses is an oral fluid test from the US, repackaged at lower cost.

In the US, OraQuick is available at pharmacies. Other self-tests can be bought online, which doesn't have to be a bad thing, but there is some concern about people using the kits without fully understanding them.

About 14 HIV rapid diagnostic tests (RDTs) have been WHO prequalified since 2010 in the USA, China, France, Canada, South Korea, Japan, Israel and Ireland. And more are in the pipeline.

In 2015, a smartphone dongle developed at Columbia Engineering performed a point-of-care HIV and syphilis test in Rwanda.

And in November 2016, Imperial College London and DNA Electronics unveiled their self-test on a USB stick. It's a lab-on-a-chip that could in future allow patients to monitor their own treatment - similar to diabetics.

"We'd normally recommend viral load testing every six months," says Dr. Graham Cooke at Imperial College. "But in areas where there's a very high-burden of HIV the diagnostics are often not there, or they are far from patients, so there's a real need to get diagnostics as close to patients as possible, and ultimately done by the patient in their own home."

An additional approach

But that's in the future. For now, the WHO is concerned with diagnosing people, and it recommends self-testing be an "additional approach to HIV testing services."

So if you use a kit and get a "reactive self-test result," you must seek further testing to confirm an HIV-positive diagnosis.

If you get a "non-reactive self-test result," it's considered a negative result (no infection). But the guidelines advise users to repeat tests if they are "at high ongoing HIV risk or if potential exposure to HIV occurred in the preceding six weeks" and they were referred to a prevention service, like post-exposure prophylaxis (PEP) or voluntary male medical circumcision.

The question is, with this significant pressure to meet the 90-90-90 targets, are we seeing this self-testing market - for that is what it is - grow faster than good advice spreads? The WHO says HIVST will "increase patient autonomy and decentralize services." But is that necessarily a good thing?

What if you had a busy night on the town and thought you could self-test for HIV the morning after? It's certainly a form of autonomy, but is it one you want?

Cooke says that there is "a need for good information around these tests - what their limitations are and the time it takes for someone to develop an antibody once they've been infected."

It can take between three and 12 weeks for enough antibodies to develop for a test to diagnose HIV infection.

Warren says the advantages outweigh any unanswered questions. "We're talking about testing people in unprecedented numbers," he said. "Home testing, self-testing, rapid testing and point-of-care diagnostics, for both the virus itself and then eventually for viral suppression assays, this is the future."